E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 6.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10052346 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To evaluate the safety of NovoSeven® in subjects with brain contusions. |
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E.2.2 | Secondary objectives of the trial |
To evaluate the preliminary efficacy of NovoSeven® in preventing early haemorrhagic progression in brain contusions. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). Signed informed consent may be obtained either from the subject and/or his/her legally acceptable representative (LAR). 2. Contusive brain injury (including brain stem) diagnosed by history, clinical examination and confirmed by CT scan within 6 hours of onset. 3. Head CT scan showing intraparencymal haemorrhage (one or more contusions) with a total minimum volume of greater than or equal to 2ml and at least one single intraparenchymal haemorrhage greater than or equal to 1ml as detected determined by the ABC/2 method. 4. Male or female subjects, age 18 years or over. 5.GCS between 4 and 14 (both inclusive) or if GCS cannot be assessed: a motor score of 2-5 (both inclusive). |
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E.4 | Principal exclusion criteria |
1. Life expectancy less than 24 hours after injury 2. Any planned surgery of parenchymal lesions in the brain within 24 hours of dosing 3. Time of CBI unknown or > 6 hours prior to initial CT scan 4. Penetrating brain injury (e.g. gunshot wounds, stab wounds) 5. Body weight greater than or equal to 160 kg 6. Spinal cord injury 7. The following CT findings in isolation: pure subarachnoid haemorrhage, pure intra-ventricular haemorrhage, pure epidural haemorrhage pure subdural haemorrhage or suspicion of a spontaneous intracerebral haemorrhage 8. Subjects with significant cardiovascular dysfunction or haemodynamic instability due to haemorrhage, e.g. systolic blood pressure 90 mmHg and/or red blood cell transfusion needed to maintain haemodynamic stability before the initial CT scan 9. Subjects scheduled to surgery or any other procedure that according to the judgement of the investigator will interfere with the planned study procedures 10. Subjects with known previous major cerebral diseases (traumatic or non-traumatic) with permanent neurological deficits (i.e. subjects with a pre-injury modified Rankin Score of 3 or higher) 11. Known history of hypercoagulable state and/or thromboembolism (e.g. ischemic stroke, DVT, PE or AMI) 12. Known thrombocytopenia (thrombocytes < 50 x 10 x9/l) 13. Known current use of vitamin K-antagonists unless INR < 1.4 14. Pregnancy 15. Known or suspected allergy to trial product or related products 16. Previous participation (randomised) in this trial 17. Known receipt of any investigational drug within 30 days prior to this trial 18. Any other condition which, in the judgement of the investigator, might increase the risk to the subject or preclude the satisfactory ability to collect experimental data
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E.5 End points |
E.5.1 | Primary end point(s) |
The occurrence of all reported serious adverse events within the first 15 days after contusive brain injury. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Please refer to protocol. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |